Reported Reactions

Devices › Clamp, vascular

Device brand name · Clamp vascular

Tr Band: medical device reports filed with FDA

1,273 reports name it, 2010–2026. Manufacturer given most often on reports: Terumo Medical. Product code DXC.

1,273
device reports naming the brand
0% of all MAUDE reports · about 78 a year
571
reports, 12 months to August 2026
91 in the 12 months before
82.8%
classified as malfunction
88% across the product code
0.2%
classified as death, as reported
2 reports · not verified by FDA

FDA's MAUDE database holds 1,273 reports that name the brand "Tr Band" (clamp vascular), received between April 2010 and August 2026; the manufacturer given most often on reports is Terumo Medical. Spellings of one product vary from report to report.

571 reports arrived in the 12 months to August 2026, up 527% from 91 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (82.8%), injury (17%) and death (0.2%); across all clamp, vascular reports (product code DXC) death is recorded in 0.6% and malfunction in 88%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are gas/air leak (46.7%), unintended deflation (28.2%) and deflation problem (14.1%). The patient problems coded most often are hematoma, blood loss and hemorrhage/blood loss/bleeding. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

055109Sep 2021: 1Oct 2021: 1Nov 2021: 0Dec 2021: 32022Jan 2022: 4Feb 2022: 0Mar 2022: 4Apr 2022: 2May 2022: 2Jun 2022: 1Jul 2022: 0Aug 2022: 1Sep 2022: 1Oct 2022: 0Nov 2022: 1Dec 2022: 52023Jan 2023: 1Feb 2023: 2Mar 2023: 16Apr 2023: 12May 2023: 54Jun 2023: 49Jul 2023: 7Aug 2023: 2Sep 2023: 1Oct 2023: 3Nov 2023: 6Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 1Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 1Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 3Dec 2024: 52025Jan 2025: 5Feb 2025: 15Mar 2025: 10Apr 2025: 8May 2025: 6Jun 2025: 13Jul 2025: 15Aug 2025: 11Sep 2025: 5Oct 2025: 14Nov 2025: 8Dec 2025: 172026Jan 2026: 11Feb 2026: 7Mar 2026: 67Apr 2026: 92May 2026: 109Jun 2026: 96Jul 2026: 81Aug 2026: 64

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

02645272010: 620102012: 142013: 2020132014: 312015: 1620152016: 992017: 4820172018: 312019: 5820192020: 602021: 5220212022: 212023: 15320232024: 102025: 12720252026: 527

Event type and report source

Event type, as classified on the report

Death0.2%2
Injury17%217
Malfunction82.8%1,054
Other0%0
Not given0%0

Who filed the report

Manufacturer report96.4%1,227
Voluntary report0.8%10
User facility report0%0
Distributor report0%0
Not given2.8%36

Grey bar: all 13,077 reports carrying product code DXC. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Gas/air leak59446.7%5.8%
Unintended deflation35928.2%2.8%
Deflation problem18014.1%2.7%
Air leak14111.1%1.2%
Inflation problem503.9%0.7%
Leak/splashthe device leaked443.5%1.1%
Filling problem181.4%0.2%
Failure to seal131%0.2%
Breakthe device broke90.7%2.3%
Material puncture/hole90.7%0.2%
Torn material80.6%0.1%
Material deformation70.5%0.1%
Material separation60.5%0.5%
Positioning problem60.5%0.5%
Device issuea problem with the device50.4%0.5%
Device operates differently than expectedthe device behaved unexpectedly40.3%8.2%
Hole in material40.3%0.1%
Material rupture40.3%0.6%
Off-label use40.3%0%
Activation, positioning or separation problem30.2%1.4%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Hematomaa collection of blood under the skin or in tissue23218.2%
Blood loss14511.4%
Hemorrhage/blood loss/bleeding876.8%
Swelling/ edema252%
Bruise/contusion191.5%
No patient involvement171.3%
Painpain, site not specified161.3%
Numbnessnumbness90.7%
Swellingswelling50.4%
Compartment syndrome40.3%
Diminished pulse pressure40.3%
Fluid discharge40.3%
Pseudoaneurysm40.3%
Air embolism30.2%
Cramp(s) /muscle spasm(s)30.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureTr BandProduct code DXCAll MAUDE reports
Reports1,27313,07726,136,888
Share of that pool—9.7%0%
Classified as death, per 1,000 reports269
Classified as injury17%10.7%36.2%
Classified as malfunction82.8%88%62.3%
Filed by the manufacturer96.4%97%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code DXC

BrandReportsLatest 12 monthsClassified as death
Guidant 4 5 Mm Heartstring Proximal Seal2,61700%
Guidant 4 5mm Heartstring Proximal Seal61500%
Tr Band Radial Compression Device29210%
Endoclamp Aortic Catheter16902.4%
Acrobat-i Stabilizer424370.2%
VasoView Hemopro 26,6336860%
Vaso View Hemopro1,83800.1%
Resolution Clip Device1,59600.3%
Vasoview 6 Pro32880%
Vasoview 7 Xb38800%
HemoPro2 Extension Cable539300%
Karl Storz63302.1%
Vasoview Hemopro 2 Evh System25900%
Hemopro2 Adaptor167140%
Vasoview Hemopro 2 With Vasoshield17600%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Tr Band reports

How many FDA reports name Tr Band?

1,273 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 571 in the latest 12 months.

What kinds of events are reported?

malfunction (82.8%), injury (17%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

gas/air leak (46.7%), unintended deflation (28.2%), deflation problem (14.1%), air leak (11.1%) and inflation problem (3.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (96.4%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Tr Band was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.